(173 days)
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Not Found
No
The device description details a chemical reaction and optical measurement method for glucose determination, with no mention of AI or ML. The performance studies focus on correlation with established methods and precision, not on training or validation of AI/ML models.
No
Explanation: The device is for in vitro diagnostic use only, specifically for the quantitative determination of glucose in whole blood, which is a diagnostic function, not a therapeutic one.
Yes
The document explicitly states in the "Intended Use / Indications for Use" section that "The GDS® GlucoSite® Test System is a device for in vitro diagnostic use only." It is designed for the "quantitative determination of glucose in whole blood," which is a diagnostic measurement.
No
The device description clearly states that the system consists of a test card, a test module, and a portable electronic reflectance photometer (Meter). This includes significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
The very first sentence of the "Intended Use / Indications for Use" section explicitly states: "The GDS® GlucoSite® Test System is a device for in vitro diagnostic use only."
Furthermore, the description details how the device is used to quantitatively determine glucose in whole blood, which is a biological sample tested in vitro (outside the body) to provide diagnostic information.
N/A
Intended Use / Indications for Use
The Stat-Site®/GlucoSite® Blood Glucose System is intended for quantitative determination of glucose in whole blood in a point-of-care setting such as a physician's office or hospital point of care sites. The test system provides glucose values equivalent to plasma glucose values. The test is not to be used at home or for neonates or children under the age of six months.
The GDS® GlucoSite® Test System is a device for in vitro diagnostic use only. The GDS® GlucoSite® Test Card is ultagi looks are quantitative determination of glucose in whole blood. It is intended for use with the Stat-Site® Meter.
Product codes (comma separated list FDA assigned to the subject device)
CGA
Device Description
This whole blood glucose test system consists of a GlucoSite® Test Card, test card specific Test Module, and a portable, hand held Stat-Site® electronic reflectance photometer (Meter). The test method employs a dry reagent technology based on the glucose oxidase method and is specific for D-Glucose. When a drop of whole blood is applied to the top opening on the test card, the red blood cells are separated allowing only the plasma to pass through. Glucose oxidase catalyzes the oxidation of the glucose in the plasma to produce gluconic acid and hydrogen peroxide in the presence of atmospheric oxygen. The second enzyme peroxidase then catalyzes the reduction of hydrogen peroxide in presence of 4-amino-antipyrine with concomitant oxidation of the chromogen TOOS [N-ethyl-N-(2-hydroxy-3sulfopropyl)-m-toluidine] to produce a purple color that is measured at 660 nm. The intensity of color developed is correlated with the glucose concentration in the whole blood sample. The Stat-Site® Meter measures the reflectance of the color produced at 660 nm and converts the reflectance reading to corresponding plasma glucose values.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Patients except neonates and children under the age of 6 months.
Intended User / Care Setting
Physician's Office or other Professional Point of Care Setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To verify safety and effectiveness of the Stat-Site®/GlucoSite® Glucose Test when used under intended use conditions such as a POL setting, the device was compared with the Hexokinase plasma glucose method and the YSI 2300 STAT PLUS Analyzer. A total of 152 venous whole blood clinical samples and 152 capillary finger stick blood samples were obtained at 3 different physician's office sites. Half of the samples were from diabetic subjects. Ten (10) more venous whole blood samples obtained in house were spiked to 3 different concentrations of glucose and were included in the study to demonstrate maximum reportable range. Whole blood samples were tested on GlucoSite® Test Cards on the Stat-Site® Meter and the results obtained were compared with the glucose values obtained when plasma from the whole blood samples was analyzed on the YSI 2300 STAT PLUS Analyzer and with Hexokinase method on the Olympus Reply Instrument.
Precision evaluation was performed at glucose concentrations of 50, 80, 150 and 350 mg/dL on 3 Stat-Site®/GlucoSite® Test Systems. Total CV's were below 5% demonstrating the performance of the Stat-Site®/GlucoSite® Glucose Test to be comparable to the claimed performance of similar meters currently in commercial distribution.
The data demonstrated that blood glucose results from Stat-Site®/GlucoSite® Test System, when used in a point of care setting such as a POL or physician's office, compare well to those of laboratory instruments such as YSI and Hexokinase method when determining plasma glucose from normal or diabetic patients.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Stat-Site®/GlucoSite® vs. YSI A. Slope = 1.008 Intercept = - 2.996 Correlation Coefficient (r) = 0.99
- Stat-Site®/GlucoSite® vs. Hexokinase B. Slope = 1.000 Intercept = -11.425 Correlation Coefficient (r) = 0.99
When the glucose data from the finger stick blood on Stat-Site®/GlucoSite® device was compared with plasma glucose values of the same subject obtained from venous blood using YSI, the predicate method, the following regression equation was obtained with 'r' value of 0.965: y = 0.999 (x) + 5.473 Where y = Stat-Site®/GlucoSite® glucose result and x = Plasma glucose result from YSI.
A similar regression was obtained when compared with Hexokinase method with 'r' value of 0.965.
Precision evaluation: Total CV's were below 5%.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
. 1 . 1 . 1 . 1 . 1 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . 2 . Division of GDS Technology, Inc 25235 Leer Drive PO. Box 473 Elkhart, IN 46515
(219) 262-0109
SEP 1 7 1997
510(k) Summary
Submitter Identification:
GDS® Diagnostics A Division of GDS® Technology, Inc. 25235 Leer Drive Elkhart, IN 46514 (219) 264-7384 Fax: (219) 262-0109
John W. Swatosh March 27, 1997
GlucoSite® Test System Blood Glucose Test System Glucose Test System YSI 2300 STAT PLUS Analyzer
Contact: Date:
Trade Name: Common Name: Classification Name: Comparison Device:
Device Description:
This whole blood glucose test system consists of a GlucoSite® Test Card, test card specific Test Module, and a portable, hand held Stat-Site® electronic reflectance photometer (Meter). The test method employs a dry reagent technology based on the glucose oxidase method and is specific for D-Glucose. When a drop of whole blood is applied to the top opening on the test card, the red blood cells are separated allowing only the plasma to pass through. Glucose oxidase catalyzes the oxidation of the glucose in the plasma to produce gluconic acid and hydrogen peroxide in the presence of atmospheric oxygen. The second enzyme peroxidase then catalyzes the reduction of hydrogen peroxide in presence of 4-amino-antipyrine with concomitant oxidation of the chromogen TOOS [N-ethyl-N-(2-hydroxy-3sulfopropyl)-m-toluidine] to produce a purple color that is measured at 660 nm. The intensity of color developed is correlated with the glucose concentration in the whole blood sample. The Stat-Site® Meter measures the reflectance of the color produced at 660 nm and converts the reflectance reading to corresponding plasma glucose values.
Intended Use:
The Stat-Site®/GlucoSite® Blood Glucose System is intended for quantitative determination of glucose in whole blood in a point-of-care setting such as a physician's office or hospital point of care sites. The test system provides glucose values equivalent to plasma glucose values. The test is not to be used at home or for neonates or children under the age of six months.
1
Comparison:
iparioon.
To verify safety and effectiveness of the Stat-Site®/GlucoSite® Glucose Test when used under intended use conditions such as a POL setting, the device was compared with the Hexokinase plasma glucose method and the YSI 2300 STAT PLUS Analyzer. A total of 152 venous whole blood clinical samples and 152 capillary finger stick blood samples were obtained at 3 different physician's office sites. Half of the samples were from diabetic subjects. Ten (10) more venous whole blood samples obtained in house were spiked to 3 different concentrations of glucose and were included in the study to demonstrate maximum reportable range. Whole blood samples were tested on GlucoSite® Test Cards on the Stat-Site® Meter and the results obtained were compared with the glucose values obtained when plasma from the whole blood samples was analyzed on the YSI 2300 STAT PLUS Analyzer and with Hexokinase method on the Olympus Reply Instrument. The following regression parameters were obtained comparing (A) Stat-Site®/GlucoSite Test System (y) with YSI(x) and (B) Stat-Site®/GlucoSite® Test System(y) with Hexokinase results (x).
- Stat-Site®/GlucoSite® vs. YSI A. Slope = 1.008 Intercept = - 2.996 Correlation Coefficient (r) = 0.99
- Stat-Site®/GlucoSite® vs. Hexokinase B. Slope = 1.000 Intercept = -11.425 Correlation Coefficient (r) = 0.99
When the glucose data from the finger stick blood on Stat-Site®/GlucoSite® device was compared with plasma glucose values of the same subject obtained from venous blood using YSI, the predicate method, the following regression equation was obtained with 'r' value of 0.965:
y = 0.999 (x) + 5.473
Where y = Stat-Site®/GlucoSite® glucose result and
x = Plasma glucose result from YSI.
A similar regression was obtained when compared with Hexokinase method with 'r' value of 0.965.
Precision evaluation was performed at glucose concentrations of 50, 80, 150 and 350 mg/dL on 3 Stat-Site®/GlucoSite® Test Systems. Total CV's were below 5% demonstrating the performance of the Stat-Site®/GlucoSite® Glucose Test to be comparable to the claimed performance of similar meters currently in commercial distribution.
Conclusion:
The data demonstrated that blood glucose results from Stat-Site®/GlucoSite® Test System, when used in a point of care setting such as a POL or physician's office, compare well to those of laboratory instruments such as YSI and Hexokinase method when determining plasma glucose from normal or diabetic patients.
2
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged on a single line, with "Public" and "Health" being slightly larger than "Service". The text is black against a white background.
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
SEP 17 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
| Regulatory Affairs |
|---|
| GDS Diagnostics |
| 25235 Leer Drive |
| Elkhart, IN 46515 |
| Re: | K971145/S1 |
|---|---|
| GlucoSite® Test System/GlucoSite® Test Cards and Test Module | |
| Regulatory Class: | II |
| Product Code: | CGA |
| Dated: | June 4, 1997 |
| Received: | June 10, 1997 |
Dear Mr. Swatosh:
Mr. John W. Swatosh
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
GlucoSite® 510(k) Submission
GlucoSite® 510(k) Submission
1000007 - 1007 Glucoon
March 27, 1997 Page 7 of 91
Indications for Use Statement 8.1
Pursuant to the Notice of 2/6/96 regarding listing of Indications for Use on a separate sheet, the following is provided.
(To be assigned) 510(k) Number __
GlucoSite® Test System Device Name:
Indications for Use:
The GDS® GlucoSite® Test System is a device for in vitro diagnostic use only. The GDS® GlucoSite® Test Card is ultagi looks are quantitative determination of glucose in whole blood. It is intended for use with the Stat-Site® Meter.
Patients except neonates and children under the Targeted population: age of 6 months.
Physician's Office or other Professional Point of Environment of Use: Care Setting
(Division Sign-Off)
Division of Clinical Laboratory Zevices
510(k) Number 477/14